(22 days)
Not Found
No
The summary describes a standard electronic thermometer with no mention of AI or ML capabilities.
No.
This device is for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. While a thermometer measures a physiological parameter (body temperature), it does not, by itself, diagnose a disease. It provides data that a healthcare professional might use as part of a diagnostic process, but it is not a diagnostic device itself.
No
The device description explicitly states "Electronic Thermometer" and describes physical components like a "plastic end" and a "molded Teddy Bear," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Standard Thermometer measures body temperature directly from the patient (orally, rectally, or axillarily). It does not analyze specimens taken from the body.
Therefore, it falls under the category of a general medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
Product codes
FLL
Device Description
Electronic Thermometer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and over-the-counter users.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
510k Submission Global Treasures Industrial, Inc. Standard Thermometer
510 (K) SUMMARY
Date of Summary
January 26, 2003
Product Name:
Standard Thermometer
Manufacturer:
Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. , HK
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: GT010706 Digital Thermometer (K021052) Manufactured by: Global Treasures Industrial, Inc.
Product Description:
Electronic Thermometer
Intended Use:
The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
Performance Characteristics:
The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity).
Conclusion:
The Standard Thermometer substantially equivalent to the electronic thermometer manufactured by Global Treasures, GT010706 Digital Thermometer (K021052).
Sponsor Global Treasures, Industrial, Inc. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun, N.T., HK
MAR 2 5 2003
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The words "HUMAN SERVICES - USA" are arranged in a circular fashion at the top of the logo, and the word "DEPARTMENT" is at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Global Treasure Industries Limited C/O Ms. Fran White MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K030658
Trade/Device Name: Standard Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 25, 2003 Received: March 3, 2003
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. White
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Ranses
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510k Submission Global Treasures Industrial, Inc. Standard Thermometer
510(k) Number:
Standard Thermometer Device Name:
Indication for Use:
The Standard Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use (Optional Format 1-2-96)
Patricia Cucurite
Division Sian-C tivision of Anesthesiology. General Hospital. Infection Control. Denta
510(k) Number: K030658